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Diss Factsheets
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EC number: 256-370-0 | CAS number: 49556-16-3
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
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Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation, other
- Remarks:
- adequate data from an LLNA study is available
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 2011-03-08 to 2011-03-23
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 011
- Report date:
- 2011
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: OECD Guideline 442B (Skin Sensitisation: Local Lymph Node Assay: BrdU-ELISA
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- Hexanoic acid, 3,5,5-trimethyl-, tin (2+)salt (2:1)
- EC Number:
- 700-567-0
- Cas Number:
- 1231728-34-9
- Molecular formula:
- C18H34O4Sn
- IUPAC Name:
- Hexanoic acid, 3,5,5-trimethyl-, tin (2+)salt (2:1)
- Test material form:
- liquid: viscous
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Harlan Winkelmann GmbH, Borchen, Germany
- Age at study initiation: approx. 12 weeks at start of the main experiment
- Weight at study initiation: 23.3 ± 1.6 g at start of the main experiment
- Housing: Single housed in Makrolon - cages Type III
- Diet (e.g. ad libitum): Altromin 1324 ad libitum
- Water (e.g. ad libitum): ad libitum, tap water
- Acclimation period: Before the main experiment was started, the animals had an acclimatisation period after delivery of 16 days.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3
- Humidity (%): 30 - 70
- Air changes (per hr): 8 TIMES/HOUR
- Photoperiod (hrs dark / hrs light): 2 hours dimmed Iight, 12 hours dark
IN-LIFE DATES: From: To: 2011-03-01 to 2011-03-23
Results and discussion
- Positive control results:
- For the reference substance a Stimulation Index of 3.09 was determined indicating the adequate function of the test system.
In vivo (LLNA)
Results
- Parameter:
- SI
- Remarks on result:
- other: Test substance: 50 % SI=3.37 75 % SI=6.44 100 % SI=7.11 Negative control: SI=1.0
Any other information on results incl. tables
Pilot Experiment
At the daily clinical observation the animals did not show any visible symptoms of systemic toxicity. Animals showed slightly decreased or nearly unchanged body weights. Only slight local irritation was observed in the highest concentration group but ear thickness values were unaffected by the treatment with the 100 %, 75 % and 50 % (w/w) concentrations of the test substance. As no excessive local irritation and no ear thickness increase was observed in the pilot experiment the same concentrations were selected for the main experiment.
Main Experiment
Visible symptoms of systemic toxicity caused by the test substance were not observed. No unusual finding occurred. The body weight of the animals was slightly decreased. Only slight symptoms of local irritation at the ears of some animals in the 75 % and 100 % test substance concentration groups and the positive control group were observed.
Test substance: 50 % SI=3.37; 75 % SI=6.44; 100 % SI=7.11
Negative control: SI=1.0
Positive control: SI=3.09
Applicant's summary and conclusion
- Interpretation of results:
- sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: other: CLP, EU GHS (Regulation (EC) No 1272/2008)
- Conclusions:
- In this Local Lymph Node Assay the test substance is a dermal sensitizer.
- Executive summary:
In a dermal sensitization study with the test substance hexanoic acid, 3,5,5-trimethyl-, tin (2+)salt (2:1) in acetone/olive oil (4:1, v/v), groups of 4 female CBA mice were tested using the LLNA method according to the OECD Guideline 442B, July 2010. BrdU was measured by ELISA using a commercial kit.
STIMULATION INDICES of 3.37, 6.44 and 7.11 were determined with the test substance at concentrations of 50 %, 75 % and 100 % (w/w) in acetone:olive oil, 4:1 (v/v), respectively.
Positive control substance was alpha hexyl cinnamic aldeyde, which gave a positive result (SI = 3.09 at a concentration of 25 % in acetone:olive oil, 4:1 (v/v).
A result is regards as positive when the SI (Stimulation Indes) is ≥ 1.6.
Based on these criteria, the test substance was found to be a sensitizer when tested from 50 % up to 100 %.
In this study, hexanoic acid, 3,5,5-trimethyl-, tin (2+)salt (2:1) is a dermal sensitizer.
According to the GHS Regulation (EC) No 1272/2008, 2nd ATP, (No 286/2011) sensitizers may be allocated to one of two sub-catogories; sub-category 1A, strong sensitisers, or subcategory 1B for other skin sensitisers. The EC3-values are used for evaluation of data from a standard LLNA, EC3-values of≤2 % are assigned to category 1A, and EC3-values of > 2 % to category 1B, respectively.
For hexanoic acid, 3,5,5-trimethyl-, tin (2+)salt (2:1) the reported SI values were 3.37, 6.44 and 7.11 for test concentrations of 50 %, 75 %, and 100%, respectively. However, no EC3-value was derived in the study report.
Hence, based on the observed dose response curve, it can be assumed that the EC3 will be well beyond the value of > 2 % and thus leading to a classification as moderate sensitizer (category 1B).
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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